We have for several years now advised in respect of a broad range of issues relating to Pharmaceuticals including the regulation and importation of medical devices and pharmaceuticals.
We have assisted clients in relation to:
- regulatory Data Protection matters including advice on the defense of Regulatory Data Protection claims;
- the Medicines Marketing Authorisations régime in Malta generally and the local process for challenging a Marketing Authorisation;
- the transposition in Malta of Medical Products Advertising law and applicable Maltese Guidelines for such advertising;
- the interruption of supply of medicinal products, wholesale distribution and inclusion in the Government Formulary list;
- Maltese regulations applicable to medical devices;
- the regulation of remuneration, gifts and honoraria applicable to healthcare professionals;
- the legal formalities and regulatory implications relevant to the wholesale distribution of pharmaceuticals outside of Malta by entities established in Malta including conditions for establishment and operations;
- Marketing Authorisations of veterinary products.
- the importation of and trade in food supplements;
- trademark registrations.
Our Pharmaceuticals Group further supports client by liaising with the relevant competent authorities including the Medicines Authority and the Malta Competition and Consumer Affairs Authority.